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A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections (RAZORBILL)

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ClinicalTrials.gov Identifier: NCT04662944
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
RAZORBILL is an observational, multicenter, multinational, open-label, study designed primarily to investigate the influence of automated OCT image enrichment with segmentation information on disease activity assessment in nAMD patients treated with licensed anti-VEGFs

Condition or disease Intervention/treatment
Neovascular Age-Related Macular Degeneration Drug: brolucizumab Drug: ranibizumab Drug: aflibercept

Detailed Description:

The main goal of this study is to assess to what degree disease activity assessment is influenced and supported by the enrichment of OCT images with segmentation information (i.e. by identification, highlighting and quantification of pathological fluid compartments associated with neovascular activity).

The study comprises a prospective data collection phase and a retrospective analysis of OCT images phase. The prospective observation period per patient will be up to 12 months.

The study will include 720 patients (naïve patients and patients who have been pre-treated with licensed anti-VEGFs not more than 3 years) being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label. Patients will be enrolled at approximately 20 centers across 6 countries.

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Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography (OCT) Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : August 2, 2022
Estimated Study Completion Date : August 2, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Licensed anti-VEGFs
Patients being treated for nAMD with licensed anti-VEGFs
Drug: brolucizumab
There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Drug: ranibizumab
There is no treatment allocation. Patients administered Ranibizumab by prescription that have started before inclusion of the patient into the study will be enrolled.

Drug: aflibercept
There is no treatment allocation. Patients administered Aflibercept by prescription that have started before inclusion of the patient into the study will be enrolled.




Primary Outcome Measures :
  1. Odds ratio of disease activity identification from Optical Coherence Tomography (OCTs) with and without automatic augmentation [ Time Frame: 12 months ]
    An odds ratio of disease activity identification from OCTs with and without automatic segmentation will be reported with a 95% confidence interval.

  2. Degree of agreement in classification of disease activity using segmented OCT images [ Time Frame: 12 months ]
    Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using segmented OCT images

  3. Degree of agreement in classification of disease activity using non-segmented OCT images [ Time Frame: 12 months ]
    Degree of agreement in classification of disease activity assessed by Krippendorff's alpha using non-segmented OCT images


Secondary Outcome Measures :
  1. Assess if Discovery is accepted by physicians and whether it can optimize the ophthalmic clinical workflow [ Time Frame: Month 12 ]
    Physicians will use a digital solution Discovery for managing imaging data and automatic segmentation of OCT volumes. To understand if such a tool is well suited for its role in its current form, holds value for physicians and can optimize clinical workflow, physicians will be invited to complete questionnaires regarding their user experience.

  2. Percentage (%) of patients absent of Subretinal Fluid, Intraretinal Fluid and Pigment Epithelium Detachment [ Time Frame: Month 12 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  3. Estimate Central Subfield Thickness (CST) change and correlation with Visual Acuity (VA) [ Time Frame: 12 months ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  4. Visual Acuity (VA) change from baseline [ Time Frame: Baseline, month 12 ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan

  5. Percentage (%) of patients with ocular and non-ocular adverse events [ Time Frame: 12 months ]
    Detailed Outcome Measure will be defined in the Statistical Analysis Plan



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 199 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects being treated for nAMD with brolucizumab, ranibizumab, or aflibercept according to the respective drug label.
Criteria

Inclusion Criteria:

  • Diagnosis of nAMD
  • Male and Female patients with ≥40 years of age at index
  • Receipt of at least one injection of brolucizumab, ranibizumab or aflibercept during the recruitment period
  • Signed written informed consent
  • Patients for whom a therapy with brolucizumab, ranibizumab or aflibercept is medically indicated according to the respective label
  • Intraretinal and/or subretinal fluid affecting the central subfield of the study eye at screening

Exclusion Criteria:

  • Patients treated for any other retinal disease than nAMD within 6 months prior to the index date (e.g. patients treated for retinal vein occlusion, diabetic macular oedema, myopic CNV, and have diagnoses of diabetes-related macular degeneration)
  • Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis >50% of the total lesion in the study eye at screening
  • Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date
  • Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)
  • Patients who have any contraindication and are not eligible for treatment with the chosen anti-VEGF treatment as according to the respective label.
  • Any medical or psychological condition, in the treating physician's opinion, which may hinder the patient from participating in this study for the expected 12 months
  • Patients participating, in parallel, in an interventional clinical trial
  • Patients participating, in parallel, in any other Novartis sponsored NIS generating primary data for an anti-VEGF drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662944


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Canada, Ontario
Novartis Investigative Site Recruiting
Toronto, Ontario, Canada, M8X 2X3
Canada, Quebec
Novartis Investigative Site Recruiting
Montreal, Quebec, Canada, H1V 1G5
Germany
Novartis Investigative Site Recruiting
Ludwigsburg, Baden-Wuerttemberg, Germany, 71638
Novartis Investigative Site Recruiting
Bonn, Germany, 53105
Novartis Investigative Site Recruiting
Duesseldorf, Germany, 40212
Novartis Investigative Site Recruiting
Muenster, Germany, 48145
Ireland
Novartis Investigative Site Recruiting
Glasnevin, Dublin 9, Ireland, D09 YN97
Novartis Investigative Site Recruiting
Waterford, Ireland
Spain
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site Recruiting
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site Recruiting
Bormujos, Sevilla, Spain, 41930
Novartis Investigative Site Recruiting
Leon, Spain, 24080
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04662944    
Other Study ID Numbers: CRTH258A2402
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
nAMD
Neovascular Age-Related Macular Degeneration
anti-VEGF
RAZORBILL
optical coherence tomography
OCT
Artificial Intelligence
Machine learning
Automatic OCT segmentation
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents